Cold and Compression After Rotator Cuff Repair (RCR)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35+
SponsorOchsner Health System
About this trial
The purpose of this study is to compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups pre-surgically, daily after surgery for 14 days, then weekly after surgery for 3 months, and at 6 months post-surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 35 yr or older
Patient of Drs. Michael Hartman (PI), Ian Elliott, Jay French, or Paul Phillips at Ochsner Kenner scheduled for arthroscopic rotator cuff repair
Will receive outpatient physical therapy at OTW Driftwood for the entire post-op rehabilitation period
English speaking
Disqualifiers
Chronic opioid use
Opioid use within the last 3 months
Diagnosis of inflammatory disease process (i.e., gout, rheumatoid arthritis, systematic lupus erythematosus...)
Discharge to skilled nursing
Trial design
Design model
Parallel
Treatments tested in this trial
SOC (Standard of care)
Other interventionPatients enrolled in this arm will be discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold therapy (bag of ice or gel pack) Other Name:
Cold and Compression
DeviceExternal mechanical compression therapy (e.g., compression stockings) has been shown to reduce swelling and risk of deep vein thrombosis in the lower limbs following TKA.12,13 Combining advanced cryotherapy (continuous circulating cold flow) and dynamic compression may offer added benefits than either traditional cryotherapy (e.g., cold packs) or compression (e.g., stockings) alone.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Standard of Care ArmActive comparator 1 intervention
Group B: Cold and CompressionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
PROMIS Pain NRS subscale
Compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups
Time frame
Enrollment to 6 months post RCRSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ochsner Health System
Lead sponsor
BREG, Inc
Collaborator
Source ClinicalTrials.gov